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Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

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ClinicalTrials.gov Identifier: NCT00144573
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 15, 2008
Sponsor:
Information provided by:
Chugai Pharmaceutical

Study Description
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Brief Summary:
This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MRA(Tocilizumab) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment
Study Start Date : January 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ]

Secondary Outcome Measures :
  1. Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, Week 4 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
  • Patients with RA at least 6 months prior to enrollment
  • Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min

Exclusion criteria

  • Patients with Class IV Steinbrocker functional impairment at enrollment
  • Patients who are undergoing dialysis
  • Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144573


Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Takahiro Kakehi Chugai Pharmaceutical
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144573     History of Changes
Other Study ID Numbers: MRA221JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 15, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Renal Insufficiency
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases